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OpenTrials
Completed

NCT Number: NCT07188181

Using AI and Fluorescence Guidance to Enhance Extrahepatic Bile Duct Identification Among Junior Surgeons During Laparoscopic Cholecystectomy

The present study evaluates whether PGY trainees and surgical residents, with or without AI assistance, could accurately identify the presence and anatomical location of the CBD, as well as delineate intraoperative danger zones during LC.

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shih Min Yin

Kaohsiung City, Kaohsiung, 83301, Taiwan

About this study

This retrospective cohort study evaluated the impact of artificial intelligence (AI) assistance on anatomical recognition during laparoscopic cholecystectomy (LC). Between June 2022 and December 2024, indocyanine green (ICG) fluorescence-guided LC videos were prospectively collected at a tertiary referral center. After excluding duplicate cases, 177 videos were used for model training, 15 for validation, and 15 for testing. Frames were extracted at 1 frame per second, and key structures including the common bile duct (CBD), cystic duct, cystic artery, liver, gallbladder, and surgical instruments were annotated by board-certified hepatobiliary surgeons to generate the ground truth dataset.

A YOLOv9 object detection model, incorporating Programmable Gradient Information (PGI) and Generalized Efficient Layer Aggregation Network (GELAN), was trained to recognize critical biliary anatomy. For the experimental phase, surgical trainees (postgraduate trainees, junior residents, and senior residents) reviewed condensed 2-3 minute surgical videos, segmented into 5-second clips. In the CBD recognition task, participants determined whether the CBD was visible in each clip. In the CBD annotation task, participants placed bounding boxes to indicate the CBD location on single frames, and additionally delineated a polygonal "dangerous zone" within Calot's triangle where further dissection is considered hazardous.

Each participant first performed both tasks without AI assistance. After a one-week washout, the same tasks were repeated with AI support, which displayed YOLOv9-generated bounding boxes to guide decision-making. The task order was randomized to minimize learning bias. Performance metrics included recognition accuracy, precision, recall, F1-score, and intersection over union (IoU).

This study was retrospectively registered after completion, as it used de-identified surgical videos and trainee assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postgraduate-year (PGY) trainees with fewer than 20 laparoscopic cholecystectomy (LC) cases.
  • Junior residents with 20-50 LC cases.
  • Senior residents with more than 50 LC cases.

Exclusion criteria

  • Participants not available for the one-week washout and repeat assessment.

Treatment and study plan

Primary outcomes

  1. CBD Recognition

    Time frame: During a single video review session (approximately 30-60 minutes per participant)

    identify the presence of the CBD

Secondary outcomes

  1. CBD annotation

    Time frame: During a single video review session (approximately 30-60 minutes per participant)

    Identify the exact location of the CBD

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

AI and Fluorescence Help Junior Surgeons Identify the Bile Duct During Laparoscopic Cholecystectomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.